Tropicamide

Product NDC
17478-102
11-digit product format
174780102
Labeler code
17478
Product ID
17478-102_b8946687-fd16-4405-8320-85fdb1f8d68b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tropicamide
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Akorn
Application
ANDA040315
Marketing category
ANDA
Marketing start
2000-09-29
Marketing end
0000-00-00
Substance
TROPICAMIDE
Active strength
10 mg/mL
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
6e36a95f-fcff-e2d1-3f9b-17d0b7f9e28cProduct name220200603
41722ce4-2429-80d8-5977-d735f8eca6d6Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17478-102-122024-01-30C16284748780-11030e365-5cef-111a-e063-dadaa90a10e2Tropicamide Ophthalmic Solution, USP
17478-102-202024-01-30C16284748780-11030e365-5cef-111a-e063-dadaa90a10e2Tropicamide Ophthalmic Solution, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-102-12Tropicamide1 in 1 CARTONSOLUTION/ DROPS18
17478-102-12Tropicamide15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS158
17478-102-20Tropicamide1 in 1 CARTONSOLUTION/ DROPS18
17478-102-20Tropicamide2 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-102-12ML - Milliliter17478-102a40716e4-abb9-40f2-9f35-a8165d94b39512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TropicamideACTIVE INGREDIENTN0A3Z5XTC6TROPICAMIDE SOLUTION/ DROPS [AKORN, INC.]2
TropicamideACTIVE MOIETYN0A3Z5XTC6TROPICAMIDE SOLUTION/ DROPS [AKORN, INC.]2
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7TROPICAMIDE SOLUTION/ DROPS [AKORN, INC.]2
edetate disodiumINACTIVE INGREDIENT7FLD91C86KTROPICAMIDE SOLUTION/ DROPS [AKORN, INC.]2
hydrochloric acidINACTIVE INGREDIENTQTT17582CBTROPICAMIDE SOLUTION/ DROPS [AKORN, INC.]2
sodium chlorideINACTIVE INGREDIENT451W47IQ8XTROPICAMIDE SOLUTION/ DROPS [AKORN, INC.]2
sodium hydroxideINACTIVE INGREDIENT55X04QC32ITROPICAMIDE SOLUTION/ DROPS [AKORN, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RTROPICAMIDE SOLUTION/ DROPS [AKORN, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-102TROPICAMIDE SOLUTION/ DROPS [AKORN]8Legacy NDC, 4 package rows20220706_329a3382-3718-4311-890f-97c6b7e0077c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313521tropicamide 0.5 % Ophthalmic SolutionPSN329a3382-3718-4311-890f-97c6b7e0077c8
314238tropicamide 1 % Ophthalmic SolutionPSN329a3382-3718-4311-890f-97c6b7e0077c8
314238tropicamide 10 MG/ML Ophthalmic SolutionSCD329a3382-3718-4311-890f-97c6b7e0077c8
313521tropicamide 5 MG/ML Ophthalmic SolutionSCD329a3382-3718-4311-890f-97c6b7e0077c8
313521tropicamide 0.5 % Ophthalmic SolutionSY329a3382-3718-4311-890f-97c6b7e0077c8
314238tropicamide 1 % Ophthalmic SolutionSY329a3382-3718-4311-890f-97c6b7e0077c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17478-102-12174780102121 BOTTLE, DROPPER in 1 CARTON (17478-102-12) > 15 mL in 1 BOTTLE, DROPPER2000-09-290000-00-00NoNoCurrent
17478-102-20174780102201 BOTTLE, DROPPER in 1 CARTON (17478-102-20) > 2 mL in 1 BOTTLE, DROPPER2000-09-290000-00-00NoNoCurrent